Instruction for use: Imogam Rabies

Dosage form: solution for injection

Active substance:

Immunoglobulinum antirabicum

ATX

J06BB05 Human anti-rabies immunoglobulin

Pharmacological group

Immunoglobulins

Nosological classification (ICD-10)

A82 Rabies:Rabies; Suspicion for rabies; Hydrophobia (hydrophobia)

Composition and release form

1 ml of injection contains human immunoglobulin for the prevention of rabies with a specific activity exceeding or equivalent to 150 IU; Thiomersal not more than 0.1 mg, glycine and sodium chloride - q.s. (To provide isotonicity, pH and stability), water for injection q.s. Up to 1 ml; In ampoules of 2 or 10 ml, in a box of 1 ampoule.

Characteristic

Pasteurized human immunoglobulin for the prevention of rabies. A buffer isotonic solution of a specific human immunoglobulin derived from blood plasma from donors immunized with an inactivated vaccine for the prevention of rabies (based on a Wistar strain grown on human diploid cell culture) and containing a high level of specific antibodies.

Pharmachologic effect

Mode action - immunostimulating.

Contains specific antibodies and forms passive immunity to the rabies virus.

Clinical Pharmacology

In comparison with heterospecific passive immunotherapy, the use of Imohmah Raz with a seroprofilactic purpose has the following advantages: there is no risk of sensitization (homologous antibodies), it is well tolerated (in the vast majority of cases), creates a longer duration of antibody presence and the possibility of achieving higher efficacy when using smaller therapeutic doses. Immediately after infection, the introduction provides passive immunity to the rabies virus, increases the duration of the incubation period, and thereby contributes to effective vaccination in carrying out complex immunoprophylaxis of rabies.

Indications of the preparation Imogam Rabies

Treatment and prophylactic and preventive immunization in rabies or suspected of it: it is recommended to immediately begin immunization (especially in young children), with any damage to the skin - bites (minor, significant, multiple), any wounds and deep scratches on the face, head, Neck, hands, feet, on the torso, inflicted by animals (sick with rabies, suspected of rabies, being under veterinary supervision and outside it, wild).

Contraindications

No (one hundred percent lethality in the disease with rabies blocks any contraindications).

Application in pregnancy and breastfeeding

Allowed.

Side effects

Local soreness is possible. Less often, minor systemic reactions with an increase in body temperature.

Interaction

Increases the effect of (mutually) rabies vaccines and is used in combination with them. A combination with an inactivated rabies vaccine prepared on a culture of human diploid cells (manufactured by Pasteur Merri Connaught) is particularly recommended, since the latter has high immunogenicity and induces active antiviral immunity. Can be used regardless of the time since infection, up to the 8th day after the first injection of rabies vaccine (the incubation period of rabies is on average 1 month, although sometimes its duration is 3-4 days). Compatible with antitetanus serum and antibiotics.

Dosing and Administration

Half (10 IU / kg) of the dose should be injected / m, the other half (another 10 IU / kg) - infiltrated around the bites (the ampule is preheated to room temperature). It is recommended as early as possible (not later than 48 hours after the alleged infection). Simultaneously, the vaccine is introduced: the site of administration of the vaccine should be removed as far as possible from the site of administration of the immunoglobulin. If the immunoglobulin was not administered concomitantly with the vaccine, it should be applied within the next 8 days.

Precautionary measures

When hypersensitivity to blood products (in the anamnesis), antihistamines should be used (with careful monitoring of the patient being necessary). Before using attenuated live virus vaccines, it is recommended to observe an interval of at least 6 weeks (preferably three months) after the introduction of immunoglobulin. IV the introduction of immunoglobulin is contraindicated (because of the risk of developing shock), so with an injection, you need to make sure that the needle has not penetrated into the blood vessel. The wound should be carefully and carefully washed first using soap or sodium hypochlorite solution, then with clean water. For disinfection, solutions of quaternary ammonium derivatives can be used, since they are characterized by high neutralizing activity against rabies viruses. Immediate suturing of the wound is contraindicated; If necessary, a simple connection of its edges is permissible.

Storage conditions of the drug Imogam Rabies

At a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Imogam Rabies

3 years.

Do not use after the expiry date printed on the package.